Abstract
Background: Mortality is often the primary outcome in randomised clinical trials (RCTs) conducted in critically ill patients. Due to increased awareness on survivors after critical illness and outcomes other than mortality, health-related quality of life (HRQoL) and days alive without life support (DAWOLS) or days alive and out of hospital (DAAOOH) are increasingly being used. DAWOLS and DAAOOH convey more information than mortality, are easier to collect than HRQoL, and are usually assessed at earlier time points, which may be preferable in some situations. However, the associations between DAWOLS–DAAOOH and HRQoL are uncertain. Methods: We will assess associations between DAWOLS–DAAOOH at day 28 and 90 (independent variables/predictors) and HRQoL assessed using the EuroQol EQ-5D-5L questionnaire (EQ-VAS and EQ-5D-5L index values) at 6 or 12 months (dependent variables) in two RCTs: the COVID STEROID 2 RCT conducted in adult patients with COVID-19 and severe hypoxaemia and the Handling Oxygenation Targets in the Intensive Care Unit (HOT-ICU) RCT conducted in adult intensive care patients with acute hypoxaemic respiratory failure. We will describe associations using best-fitting fractional polynomial transformations separately in each dataset, with the resulting models presented and assessed in both datasets graphically and using measures of fit and prediction adequacy (i.e., internal performance and external validation). We will use multiple imputation if missingness exceeds 5%. Discussion: The outlined study will provide important knowledge on the associations between DAWOLS–DAAOOH and HRQoL in adult critically ill patients, which may help researchers and clinical trialists prioritise and select outcomes in future RCTs conducted in this population.
Originalsprog | Engelsk |
---|---|
Tidsskrift | Acta Anaesthesiologica Scandinavica |
Vol/bind | 66 |
Udgave nummer | 2 |
Sider (fra-til) | 295-301 |
ISSN | 0001-5172 |
DOI | |
Status | Udgivet - feb. 2022 |
Bibliografisk note
Funding Information:The Department of Intensive Care at Rigshospitalet has received funding for other research projects from the Novo Nordisk Foundation, Pfizer, Ferring and Fresenius Kabi, and conducts contract research for AM‐Pharma (the REVIVAL trial).
Funding Information:
This study will be conducted as part of the Intensive Care Platform Trial (INCEPT; www.incept.dk ) research programme. INCEPT has received funding by Sygeforsikringen “danmark”, Grosserer Jakob Ehrenreich og Hustru Grete Ehrenreichs Fond and Dagmar Marshalls Fond. The COVID STEROID 2 trial was funded by the Novo Nordisk Foundation and supported by Rigshospitalet; the HOT‐ICU trial was funded by the Innovation Fund Denmark, Aalborg University Hospital, the Regions of Denmark, the Obel Family Foundation, the Danish Society of Anaesthesiology and Intensive Care Medicine, and the Intensive Care Symposium Hindsgavl. None of the funders had any influence on any aspects of this study.
Publisher Copyright:
© 2021 The Acta Anaesthesiologica Scandinavica Foundation